Kennedy’s lawyer has asked the FDA to revoke its approval of the polio vaccine

CNN
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President-elect Donald Trump has hailed the polio vaccine as the “best thing,” but a lawyer associated with Trump’s pick to lead the nation’s top health agency has petition US Food and Drug Administration to revoke the approval of the vaccine used in the United States.

The attorney, Aaron Siri, filed the petition in 2022 on behalf of the Informed Consent Action Network, or ICAN, a nonprofit challenging vaccine safety and vaccine mandates. Siri has worked closely with Robert F. Kennedy Jr. — a vaccine skeptic and Trump’s pick to lead the U.S. Department of Health and Human Services — to select officials to serve in the incoming administration. He was also Kennedy’s personal attorney during his own presidential campaign.

“FDA continues to review the petition,” an agency spokesman said in an email to CNN on Friday. “We cannot predict when the reviews will be completed. FDA will consider the concerns outlined in the petition as a final decision is made. FDA will respond directly to the petitioner, and this response will be placed on the table. Until then We cannot comment further.”

If Kennedy is confirmed to head HHS, he will oversee the FDA and could take the rare step of intervening in its petition review. In one recent interviewKennedy told NBC News that he would not take away anyone’s vaccines, but said, “People should have a choice, and that choice should be informed by the best information.”

Trump told Time magazine in an interview conducted in late November but published this week that more research will be underway and that he would consider getting rid of some vaccines for children, “if I think it is dangerous if I think they are not beneficial.”

But Trump has also praised polio vaccination.

“The polio vaccine is the biggest thing. If somebody told me to get rid of the polio vaccine, they’re going to have to work hard to convince me,” Trump told NBC’s “Meet the Press” in an interview that aired Sunday.

The petition and Kennedy’s association with the lawyer who filed it first reported by the New York Times.

CNN reached out to Trump’s transition team and ICAN for comment, but did not hear back.

Senate Minority Leader Mitch McConnell, himself a polio survivor, issued a warning about the problem Friday, apparently aimed at Kennedy.

“The polio vaccine has saved millions of lives and delivered on the promise of eradicating a terrible disease,” he said in a statement. “Efforts to undermine public confidence in proven cures are not just uninformed – they are dangerous. Anyone seeking Senate consent to serve in the incoming administration would do well to avoid even apparent association with such efforts.”

Polio vaccination is considered one of the greatest achievements in global public health. it was once a disease that paralyzed and killed thousands of Americans during outbreaks, but the advent of a vaccine in the 1950s has greatly reduced its incidence around the world, setting the target disease control on the verge of becoming a reality.

In the 1950s, before a vaccine was available, polio killed or paralyzed more than half a million people globally each year, according to World Health Organization.

Siri’s petition asks the FDA to withdraw or suspend approval of the inactivated poliomyelitis vaccine until “a properly controlled and properly conducted double-blind trial of sufficient duration is conducted to assess the safety of this product.”

Siri filed the petition the same year New York health officials ramped up polio vaccine campaigns after a young, unvaccinated adult was paralyzed by the infection and the virus turned up in local sewage. That case was the first in the United States in nearly a decade.

The petition relies on what sounds like an alarming fact—that there was no placebo-controlled clinical trial to prove the vaccine’s safety—but experts say it distorts reality to make it appear that the risks of polio vaccination can outweigh the benefits, which is not true.

In fact, placebo-controlled trials are not considered ethical for most vaccines because a portion of the people who participate in them would not get the shot, leaving them unprotected. Polio does not circulate widely, and it would not be ethical to deliberately infect a healthy person with the virus. There is no cure for polio, and a person who is unprotected can be paralyzed for life.

“You’re replacing a theoretical risk with a real risk,” said Dr. Paul Offit, a vaccine expert at the Children’s Hospital of Philadelphia, told the New York Times. “The real risks are the diseases.”

The US Centers for Disease Control and Prevention says no serious side effects related to the use of inactivated polio vaccine has been documented. Rarely, people may have reactions to the vaccine if they are allergic to certain types of antibiotics, such as streptomycin, polymyxin B, or neomycin.

Siri’s petition focuses on the inactivated polio vaccine, which has been used in the United States for more than two decades.

The US switched away from the oral vaccine – which uses a weakened but live version of the virus – because about every 3 million times it is given, the weakened virus can cause paralysis in the vaccine recipient. However, the oral vaccine is still used in some other countries.

The inactivated polio vaccine used in the United States is given by injection and does not carry that risk, making it even safer for the people who receive it. But the injected vaccine does not create so-called mucosal immunity, which means that it does not prevent the virus from being able to infect people if it enters the body.

On the contrary, the injected vaccine protects people against this worst-case scenario: it helps the immune system recognize the virus and fight it before it reaches the nervous system.

It also doesn’t stop transmission of the virus because people who get it can still become infected and shed the virus in their stool.

In the United States, however, this has not been a problem because poliovirus – thanks to vaccination – does not normally circulate.

Poliovirus spreads from person to person through the fecal-oral route. People infect each other when they get the virus on their hands after using the bathroom and then shake hands or touch surfaces.

The weakened virus from the oral vaccine can also be shed in the feces, and this can become a problem in populations that are not adequately vaccinated. If this transmission occurs in a population that is not well vaccinated, there is a chance that it could mutate back into a form that can cause paralysis.

Most of the world’s polio cases are now caused by vaccine-derived virus. In 2023, the number of polio cases caused by vaccine-derived strains was 524, down from 881 in 2022.

CNN’s Manu Raju and Morgan Rimmer contributed to this report.